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NCT04944940 · ClinicalTrials.gov registry record
Clinical, Molecular and Imaging Biomarkers in Spinal and Bulbar Muscular Atrophy (SBMA)
A clinical trial of Motor Neuron Disease and Spinal and Bulbar Muscular Atrophy, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Recruiting
- Registry status
- 70
- Enrollment target
- 1
- Study location
NCT04944940 is a study of Motor Neuron Disease and Spinal and Bulbar Muscular Atrophy that is actively recruiting participants, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 70 participants, below the 526-participant average among 17 other Motor Neuron Disease trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04944940, a study of Motor Neuron Disease and Spinal and Bulbar Muscular Atrophy, is actively recruiting participants, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- RECRUITING
- Registry status
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: SBMA is an inherited chronic disease. It affects males in mid to late adulthood. It causes slowly progressive weakness of muscles and hand tremors. Researchers want to learn more about the effects of SBMA. Objective: To identify measurements that change over time in SBMA, including tests of muscle strength and function, as well as measurements of muscle and fat size. Eligibility: Men over the age of 18 both with and without a history of SBMA. Design: Participants will have a medical history, physical exam, and blood and urine tests. They will have neuromuscular ultrasound. They will have a lumbar puncture to obtain spinal fluid. For this, a needle will be inserted into the spinal canal in the lower back. Participants will have muscle strength and function tests. These tests may include pushing, pulling, rising from a chair and sitting back down, and/or walking. During these tests, they may wear an accelerometer (activity tracker) on their wrist. Participants will get an activity tracker to wear on their wrist for 10 days at home every 3 months. Participants with SBMA will also have lower limb magnetic resonance imaging (MRI) and optional whole-body MRI. They will have lung function tests. They will have speech and swallow tests. They will complete questionnaires. They may have optional body scans to measure bone density and lean body mass. They may have optional muscle biopsies. For biopsies, a needle will be used to take a small piece of muscle from the leg. Participants with SBMA will have 5 study visits over 2 years (every 6 months). Participants without SBMA will have 1 study visit.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2021-10-25 |
| Est. Completion | 2027-02-28 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04944940
The ClinicalTrials.gov registry entry for NCT04944940 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 526-participant average among 17 other Motor Neuron Disease trials with a reported enrollment target (87% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Motor Neuron Disease appearing as the primary indexed condition, and to 0 interventions.
NCT04944940 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04944940 about?
NCT04944940 is a clinical study titled "Clinical, Molecular and Imaging Biomarkers in Spinal and Bulbar Muscular Atrophy (SBMA)". Background: SBMA is an inherited chronic disease. It affects males in mid to late adulthood. It causes slowly progressive weakness of muscles and hand tremors. Researchers want to learn more about the effects of SBMA. Objective: To identify measurements that change over time in SBMA, including te...
What is the current status of trial NCT04944940?
This trial is currently recruiting. The enrollment target is 70 participants. The study started on 2021-10-25. Estimated completion is 2027-02-28.
What conditions does trial NCT04944940 study?
This clinical trial studies the following conditions: Motor Neuron Disease, Spinal and Bulbar Muscular Atrophy, Kennedys Disease.
Who is sponsoring clinical trial NCT04944940?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04944940 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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